69 FR 73 pg. 20012 - Notice of Approval of New Animal Drug Application;Ceftiofur
Type: NOTICEVolume: 69Number: 73Page: 20012
FR document: [FR Doc. 04-8513 Filed 4-14-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Notice of Approval of New Animal Drug Application;Ceftiofur
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isproviding notice that it has approved a supplemental new animal drugapplication (NADA) filed by Pharmacia Upjohn, Co. The supplementalNADA provided revised susceptibility information for equine pathogenslisted in the clinical microbiology section of labeling for ceftiofursodium sterile powder for injection and added interpretive criteria. Theapplicable section of the regulations did not require amendment.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson,Center for Veterinary Medicine (HFV-110), Food and DrugAdministration, 7500 Standish Pl., Rockville, MD 20855,301-827-7540, e-mail: melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION:
Pharmacia Upjohn, Co., 7000 Portage Rd., Kalamazoo, MI49001-0199, filed a supplement to NADA 140-338 which providesfor the veterinary prescription use of NAXCEL (ceftiofur sodium) SterilePowder for Injection. The supplemental NADA provided updatedsusceptibility data for equine respiratory pathogens listed in the clinicalmicrobiology section of labeling and added the National Committee forClinical Laboratory Standards' interpretive criteria for equine isolates.In accordance with section 512(i) of the Federal Food, Drug, and CosmeticAct (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 514.106(a), FDA isproviding notice that this supplemental NADA is approved as of February 27,2004. The basis of approval is discussed in the freedom of information(FOI) summary.
In accordance with the FOI provisions of 21 CFR part 20 and 21 CFR514.11(e)(2)(ii), a summary of safety and effectiveness data andinformation submitted to support approval of this application may be seenin the Division of Dockets Management (HFA-305), Food and DrugAdministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action isof a type that does not individually or cumulatively have a significanteffect on the human environment. Therefore, neither an environmentalassessment nor an environmental impact statement is required.
Dated: March 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center forVeterinary Medicine.
[FR Doc. 04-8513 Filed 4-14-04; 8:45 am]
BILLING CODE 4160-01-S